Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1264 participants
INTERVENTIONAL
2007-07-31
2013-10-31
Brief Summary
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Detailed Description
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One thousand two hundred sixty-four (1264) subjects will be treated with either the TAXUS® Element™ stent or the TAXUS® Express2 ™stent at a maximum of 100 clinical sites. Randomization to treatment group will be unbalanced 3:1 towards the test group to gain maximum clinical experience with the new TAXUS® Element™ platform. Follow-up at 30 days, 9 months and 12 months will be completed in all subjects enrolled in the study. Angiographic follow-up at 9 months will be completed in a subset of three hundred thirty (330) subjects enrolled in the study. Subjects will be randomly allocated to the angiographic subset at participating sites through the Interactive Voice Response System (IVRS).
Eligible subjects will have annual follow-up until 5 years post-index procedure.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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TAXUS Element
Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement
TAXUS Express
Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant
Interventions
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Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Element) implantation
TAXUS Element stent placement
Percutaneous coronary intervention (PCI) with paclitaxel-eluting stent (TAXUS Express) placement
TAXUS Express Stent Implant
Eligibility Criteria
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Inclusion Criteria
* Eligible for percutaneous coronary intervention (PCI)
* Documented stable angina pectoris (Canadian Cardiovascular Society \[CCS\] Classification 1, 2, 3, or 4) or unstable angina pectoris (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia
* Acceptable candidate for coronary artery bypass grafting (CABG)
* Left ventricular ejection fraction (LVEF) is ≥ 30%
* Subject (or legal guardian) understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
* Subject willing to comply with all specified follow-up evaluations
* Target Lesion
* Target lesion located in native coronary artery
* Target lesion must be de novo
* Target lesion diameter stenosis ≥ 50%
* Reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 4.0 mm
* Cumulative target lesion length ≤ 28 mm (area to be treated may be composed of multiple lesions but must be completely coverable by one study stent)
* Target lesion is successfully pre-dilated
* One non-target lesion may be treated in a non-target vessel as follows:
* Non-target lesion in non-target vessel must be treated with commercially available TAXUS stent if use of drug eluting stent required
* Treatment must be deemed a clinical angiographic success, without requiring use of unplanned additional stents(s)
* Treatment must be completed prior to treatment of target vessel
Exclusion Criteria
* Known hypersensitivity to paclitaxel
* Known allergy to stainless steel
* Known allergy to platinum
* Previous treatment of the target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent
* Previous treatment of the target vessel with a bare metal stent (BMS) within 9 months of the index procedure
* Previous treatment of any non-target vessel with any anti-restenotic drug-coated or drug-eluting coronary stent within 9 months of the index procedure
* Previous treatment with intravascular brachytherapy in the target vessel
* Planned PCI or CABG post-index procedure
* Planned or actual target vessel treatment with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter immediately prior to stent placement
* Myocardial infarction (MI) within 72 hours prior to index procedure
* Cerebrovascular accident (CVA) within the past 6 months
* Cardiogenic shock
* Acute or chronic renal dysfunction
* Prior anaphylactic reaction to contrast agents
* Leukopenia
* Thrombocytopenia
* Thrombocytosis
* Active peptic ulcer or active gastrointestinal (GI) bleeding
* Current treatment, or past-treatment within 12-months of the index procedure, with paclitaxel or other chemotherapeutic agents
* Anticipated treatment with paclitaxel or oral rapamycin during any period in the 9-months after the index procedure
* Known intention to procreate within 9 months after the index procedure
* Positive pregnancy test within 7 days before the index procedure, or lactating
* Life expectancy of less than 24 months due to other medical conditions
* Co-morbid condition(s) that could limit subject's ability to comply with study follow-up requirements or impact study scientific integrity
* Currently participating in another investigational drug or device study
* Target lesion located in left main artery, whether protected or unprotected
* Target lesion is a chronic total occlusion (TIMI flow ≤ 1)
* Target lesion is restenotic
* Target lesion is located in a saphenous vein graft or mammary artery graft
* Target lesion is accessed via saphenous vein graft or mammary artery graft
* Target lesion is \< 5 mm from bare metal stent (BMS)
* Target lesion \< 5 mm from ostium
* Target lesion \< 5 mm from side branch vessel ≥ 2.0 mm in diameter (Exceptions: subject may be enrolled if side branch is 100% occluded or if side branch is protected with a patent graft)
* Untreated lesions with ≥ 50% diameter stenosis or thought to impair flow remaining in target vessel at a location with ≥ 2.0mm RVD
* Target lesion and/or target vessel proximal to target lesion moderately or severely calcified
* Target lesion and/or target vessel proximal to target lesion severely tortuous
* Target lesion located within or distal to a \> 60° bend in target vessel
* Target vessel with angiographic presence of probable or definite thrombus
* Unprotected left main coronary artery disease
* Protected left main coronary artery disease with target lesion in Left Anterior Descending artery (LAD) or Left Circumflex artery (LCx). Subject may be enrolled if only lesion is target lesion in Right Coronary Artery (RCA)
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Dean J Kereiakes, MD
Role: PRINCIPAL_INVESTIGATOR
The Christ Hospital
Louis A Cannon, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiac and Vascular Research Center of Northern Michigan
Locations
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Baptist Medical Center Princeton
Birmingham, Alabama, United States
Medical Center East
Birmingham, Alabama, United States
Bakersfield Memorial Hospital
Bakersfield, California, United States
Alvarado Hospital
La Jolla, California, United States
Scripps Clinic
La Jolla, California, United States
Scripps Memorial Hospital
La Jolla, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Mercy General Hospital
Sacramento, California, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
Christiana Hospital
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Mediquest Research at Munroe Regional Medical Center
Ocala, Florida, United States
Florida Hospital
Orlando, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tallahassee Memorial Hospital
Tallahassee, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
Medical Center of Central Georgia
Macon, Georgia, United States
Kaiser Foundation Hospitals
Honolulu, Hawaii, United States
Evanston Northwestern
Evanston, Illinois, United States
St. Anthony's Medical Center
Rockford, Illinois, United States
St. John's Hospital
Springfield, Illinois, United States
Northern Indiana Research Alliance / Lutheran Hospital of Indiana
Fort Wayne, Indiana, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
St. Vincent's Hospital
Indianapolis, Indiana, United States
Trinity Terrace Park
Davenport, Iowa, United States
Iowa Heart Center
Des Moines, Iowa, United States
Maine Medical Center
Portland, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Washington Adventist Hospital
Takoma Park, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Cape Cod Research Institute
Hyannis, Massachusetts, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Lakeland Hospitals at St. Joseph
Saint Joseph, Michigan, United States
St. Mary's Duluth Clinic Regional Heart Center
Duluth, Minnesota, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
Mercy Hospital
Minneapolis, Minnesota, United States
North Mississippi Medical Center
Tupelo, Mississippi, United States
St. Anthony's Medical Center
St Louis, Missouri, United States
Nebraska Heart Hospital
Lincoln, Nebraska, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Heart Hospital of New Mexico
Albuquerque, New Mexico, United States
St. Joseph's Hospital Health Center
Liverpool, New York, United States
Lenox Hill Hospital
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
LeBauer Cardiovascular Research Foundation
Greensboro, North Carolina, United States
Wake Medical Center
Raleigh, North Carolina, United States
Forsyth Medical Center
Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
St. Vincent Mercy Medical Center
Toledo, Ohio, United States
Oklahoma Foundation for Cardiovascular Research
Oklahoma City, Oklahoma, United States
Providence St. Vincent Medical Center
Portland, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Main Line Health Heart Center
Bryn Mawr, Pennsylvania, United States
Lancaster General Hospital
Lancaster, Pennsylvania, United States
St. Mary Medical Center
Langhorne, Pennsylvania, United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, United States
University Medical Center-Greenville Memorial Hospital
Greenville, South Carolina, United States
Wellmont Holston Valley Medical Center
Kingsport, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
Methodist DeBakey Heart Center
Houston, Texas, United States
TexSAn Heart Hospital
San Antonio, Texas, United States
Trinity Mother Frances Health System
Tyler, Texas, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Lynchburg General Hospital
Lynchburg, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Sacred Heart Medical Center
Spokane, Washington, United States
St. Mary's Medical Center
Huntington, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
CaRE Foundation, Inc.
Wausau, Wisconsin, United States
Royal Adelaide Hospital, Adelaide, SA, Australia
Adelaide, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincents Public,
Fitzroy, Victoria, Australia
Auckland City Hospital
Auckland, , New Zealand
Christchurch Hospital
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Wellington Hospital
Wellington, , New Zealand
National Heart Centre
Singapore, , Singapore
Countries
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References
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Kereiakes DJ, Cannon LA, Feldman RL, Popma JJ, Magorien R, Whitbourn R, Dauber IM, Rabinowitz AC, Ball MW, Bertolet B, Kabour A, Foster MC, Wang JC, Underwood P, Dawkins KD. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial. J Am Coll Cardiol. 2010 Jul 20;56(4):264-71. doi: 10.1016/j.jacc.2010.04.011. Epub 2010 May 20.
Allocco DJ, Cannon LA, Britt A, Heil JE, Nersesov A, Wehrenberg S, Dawkins KD, Kereiakes DJ. A prospective evaluation of the safety and efficacy of the TAXUS Element paclitaxel-eluting coronary stent system for the treatment of de novo coronary artery lesions: design and statistical methods of the PERSEUS clinical program. Trials. 2010 Jan 7;11:1. doi: 10.1186/1745-6215-11-1.
Other Identifiers
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S2037-PIVOT-2006
Identifier Type: -
Identifier Source: secondary_id
S2037
Identifier Type: -
Identifier Source: org_study_id
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